Pending 510(k) Decision for Leo Cancer Care Paves the Way for New Era of Patient Cancer Care

Wisconsin, US - September 28th, 2023 - Leo Cancer Care’s revolutionary patient positioning system designed to deliver radiation therapy in a more ‘human way’ for cancer patients has taken a critical step towards 510(k) regulatory clearance.

With the regulatory decision for the innovative system now pending, 510(k) clearance will mean the upright technology will have the capability to be used in patient care in centres across the United States in the near future.

Leo Cancer Care CEO Stephen Towe said: “This is a highly significant milestone for our company; 510(k) submission is an important step forward in our drive to see cancer therapy delivered to patients in a more human way.”

Treatment in the upright position

The 510(k) clearance process is a way by which medical device manufacturers can obtain clearance from the Food and Drug Administration (FDA) and gives a company permission to market its product.

Leo Cancer Care’s patient positioning system enables cancer patients to receive radiation treatment seated in an upright position. The design is innovative compared to the majority of radiotherapy devices available today, with the patient positioning system being one part of a whole solution. However, it is the element that holds the most potential, particularly from a patient treatment delivery perspective.

The aim is to improve patient experience and comfort, boost clinical effectiveness and offer better access to radiotherapy.

Research has already shown that the approach is a more natural position for patients with evidence suggesting that this will contribute to less internal organ movement leading to more accurate delivery of radiotherapy.

Smaller clinical footprint

Leo Cancer Care’s upright positioning technology takes up a significantly smaller footprint in a clinical setting than conventional rotating gantry systems where treatment is delivered to patients in the supine position. It will also be more cost-effective to install, run and maintain.

Towe pointed out that several centres across the United States have already shown their confidence in Leo Cancer Care’s upright patient positioning technology by placing orders for the system to be installed in their treatment rooms and enable patients to receive upright care at the earliest opportunity.

Please note: The Leo Cancer Care technology is not commercially available and will not treat patients until the required regulatory clearance has been achieved.